Segmented intramedullary structure
An implantable intramedullary fixation structure adapted to be received in the intramedullary canal of a long bone is disclosed comprising a plurality of elongated segments. Each segment has a first end and a complementarily-shaped second end such that the first end of a segment cooperatively engages the second end of an adjacent segment. The segments define a guide aperture so as to be receivable over a guide for positioning in the intramedullary canal.
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This application is a continuation of U.S. application Ser. No. 12/052,919, filed Mar. 21, 2008, which claims the benefit of priority from U.S. Provisional No. 60/896,342 filed Mar. 22, 2007, each of which are incorporated by reference in their entireties herein.
BACKGROUNDThe present invention relates an orthopedic prosthesis, and, more particularly, to an implantable structure, commonly called an intramedullary or IM nail, that is adapted to be received in the intramedullary canal for the treatment of long bone fractures.
SUMMARYThe intramedullary structure of the present disclosure, in one embodiment, utilizes a plurality of segments that are preferably introduced into the intramedullary canal over a guide member that has been previously introduced into the intramedullary canal through a percutaneous access hole. Each segment is preferably configured so that it interconnects with the segments adjacent thereto. Also preferably, an elongated tensioning member is received interiorly of the segments and is secured to the end segments to secure all the segments in the structure together. In one embodiment, the guide member is a wire or cable that also serves as the tensioning member.
More specifically, each segment may have an aperture, in the form of an open interior, so that the segment can be threaded over a guide or tensioning member. The segments also have opposed ends that preferably are complementarily-shaped so that an end of a first segment is adapted to cooperatively engage with the end of a second segment adjacent thereto. Preferably, each segment has a male end and a complementarily-shaped female end.
Other features and aspects will become apparent upon reference to the accompanying drawings and description.
In accordance with the present disclosure, an intramedullary structure is provided that is adapted to be received in the intramedullary canal of a long bone, such as a tibia. The structure comprises a plurality of elongated segments, with each segment having a first end and a complementarily-shaped second end, so that the first end of a segment cooperatively engages the second end of an adjacent segment. The segments preferably define a guide wire aperture so as to be receivable over a guide wire or cable for introduction into the intramedullary canal. Optionally, the structure may include a tensioning member in the form of, e.g., a cable or a rod extending the length thereof that cooperates with the end-most segments of the structure to apply a compressive force along the longitudinal axis of the structure, thus providing the structure with enhanced rigidity.
Turning to
As shown, the ends 16 of the tension rod 14 are threaded and the segments 12 are maintained thereon by complementarily threaded members (nuts 18 and washers 20 are shown) received on the threaded ends 16 of the tension rod 14. However, alternate methods for securing the segments 12 to the tension rod 14 may be employed, such as a swage fitting that is received on the tension rod and which seats in the open interior of the end segments, or a press nut received on the tension rod in engagement with the end segments.
The overall length of the segment 12 is preferably no greater than about 32 mm, which allows the segment 12 to be relatively easily introduced into the intramedullary canal through a 10 mm percutaneous access hole that is oriented at approximately 30 degrees with respect to the bone axis. The largest outside diameter of the segment 12 is dictated by the inside diameter of the intramedullary canal, and is typically about 9 mm. The inside diameter of the male end 22 of the segment is approximately 3.6 mm, which allows a 3 mm guide wire or cable to easily pass therethrough.
The segments 12 are made of a biocompatible material of sufficient rigidity and strength, such as titanium. The inside surface of the female end 24 and the outside surface of the male end 22 may be smooth (“mirror polished”) to facilitate nesting. The outside surface of the female end 24 may be roughened or textured (“knurled”) to promote tissue growth thereon.
In the illustrated embodiment, adjacent segments 12 are secured to each other by a friction fit between the inside surface of the female end and the outside surface of the male end. However, a more positive interlocking can be obtained, if desired, by providing the segments with mechanically-interlocking structures, such as slots and pins, prongs, tabs, screw threads, etc. The segments may also be configured to prevent rotational movement therebetween when assembled. This may be accomplished by, e.g., providing the outer surface of the male end and the inner surface of the female end with complementary non-circular cross sections, such as a square with rounded-off corners. Alternatively, or additionally, a bone cement or other hardenable surgical fluid may be introduced into the interior of the segments once in place in the intramedullary canal, to impart additional structural integrity for the assembly and to help secure the assembled structure in place.
With reference to
With reference to
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With reference to
The proximal end segment 110 and the intermediate segments 108 are pre-assembled, with the various segments hingedly secured to each other. In order to facilitate insertion of the fixation structure 102 into the head of a long bone, where the entry point for the implant is offset from the axis of the long bone, the various segments 108, 110 of the implantable structure are configured to be relatively moveable only axially and laterally in a single plane. To this end, and with reference to
Experience has shown that when members with smooth or regular tapered or conical surfaces nest, there is tendency for the tapered surfaces to lock together. This, of course, would be disadvantageous in the present structure, as it would result in a reduced flexibility of the implantable structure required for insertion into and removal from the intramedullary canal. Accordingly, the obliquely-oriented surfaces 118d, 120d of the male and female portions 118, 120 of the segments 108 are formed with a series of steps 122 having surfaces that are substantially parallel to the axis of the segment. This ensures that if tension is not applied to the cable 116, and the fixation structure 102 is not under compression, the mating portions of the segments freely slide apart.
The various segments 108, 110 of the structure are secured to each other in a manner that permits limited axial movement relative to the adjacent segments, and ensures the proper orientation of the faces of the male portion of a segment with the female portion of the adjacent segment. In the structure of the present embodiment, this is accomplished by providing the female portion 120 of the segment with a pin 124 (best seen in
The proximal end segment 110 has an open interior for passage of the tensioning cable and comprises two sections: an arcuate section 128 and a mating section 130, the latter having a male portion 118 as described above for seating in the female portion 120 of the immediately distal intermediate segment. To allow for fixation of the proximal end of the implantable structure to the bone, the arcuate segment includes a plurality of throughbores 112 (three shown) oriented generally perpendicular to the axis of the implantable fixation structure 102 for the receipt of bone screws (not shown). The throughbores 112 are located so as to not intersect the open interior of the arcuate section, thus ensuring that the tensioning cable 116 is not contacted by the fixation screws.
The proximal end of the arcuate section 128 is configured to receive a two-part distal collet assembly 132 (
As described in connection with the prior embodiments, the distal portion of the implantable structure can be configured to be fixed to the bone by bone screws or by bone cement. However, in the present embodiment, the fixation of the implantable structure to the distal portion of the long bone is preferably accomplished by having the distal-most segment 140 be radially expandable so as to engage the surface of the intramedullary canal. To this end, and with reference to
The illustrated expander 142 comprises an upper collar portion 146 from which depend in cantilever fashion a plurality of evenly radially-spaced legs 148 (four shown). In its undeformed state, the expander 142 has a radial dimension no greater than that of the other segments 108, 110 of the implantable fixation structure 102 in order to facilitate insertion into the intramedullary canal. The wedge member 144 is generally conical in shape, and has elongated grooves 150 in its surface for seating the legs 148 of the expander 142. Preferably, the grooves 150 have a cross-sectional shape that is complimentary to the inner surfaces of the legs 148.
In order to enhance the anchoring of the expander in the intramedullary canal, the outer surfaces of the legs may be formed with structures designed to more easily penetrate into the boney surface of the intramedullary canal. Such structures may take the form of points or a narrow edge or blade-like structure. In the illustrated embodiment, the outer surface of each leg is provided with a continuous raised spine 152. Preferably the spines 152 have a wavy or zig-zag configuration, which provides resistance to both axial and rotational movement of the embedded expander 142.
As noted above, in the present embodiment, the proximal end segment 110 includes three throughbores 112 for receiving bone screws to secure the proximal end of the implant 102 in position. To facilitate the placement of the screws, the proximal segment 110 is adapted to mount a screw guide interface 104. As best seen in
A tensioner tool assembly may be utilized to regulate and/or lock tension on the cable in the fixation device. The tensioner tool assembly may comprise a cable, a locking feature, a tensioner, and a locking mechanism actuator. Referring to
The embodiment of the tensioner tool assembly 200 comprises a proximal collet 210 which engages within a threaded shaft 220. Distal to the proximal collet is a threaded knob 240 which partially extends into a housing 230. The housing 230 is shaped to be dockable in the insertion guide 166, which can connect to the proximal end of the fixation device. A collet driver 250 is captured within the housing and is configured to be rotatable within the housing. Within the connection between the insertion guide and the fixation device is the distal collet assembly 132. A cable bore 202 extends longitudinally along a straight path within the entire length of the assembly 200.
When connecting the tensioner tool assembly 200 to the fixation device 102, first the insertion guide 166 may be guided over the cable 116 and attached to the fixation device 102, and then the remainder of the tensioner tool assembly 200 guided over the cable 116 and docked via the housing 230 within the insertion guide 166. Alternately, the tensioner tool assembly 200 may first be docked to the insertion guide 166, and the entire assembly then guided over the cable 116 and attached to the fixation device 102. Threads or other coupling features may provide an interface to dock the housing 230 to the insertion guide 166.
Referring to
The proximal collet 210 fits into the proximal end of the threaded shaft 220. External threads 212 engage with the internal threads 224 on the threaded shaft to hold the collet 210. A plurality of flexible fingers 214 extend distally from the collet 210, into the chamber 226. As previously described, the tensioner tool assembly 200 is guided over the cable 116 (not shown), and the cable extends through the cable bore 202 and out the proximal end of the proximal collet 210. The proximal collet 210 is a locking feature which may be locked onto a location on the cable by screwing the proximal collet 210 into the threaded shaft 220. As the collet 210 is screwed in, the fingers 214 advance distally into the chamber 226. As the fingers 214 bias against the tapered wall 228, they are urged together, engaging and constricting the cable, until the cable is securely gripped. As the fingers 214 engage the cable, they may circumferentially surround the cable. In this position, the cable is locked and prevented from being pulled in either direction. However, the cable can again be freely moved by simply unscrewing collet 210 from within threaded shaft 220 so that fingers 214 are able to freely, outwardly flex and disengage from the cable. It is noted that in the locking process, the cable 116 remains oriented substantially along a straight path within the assembly 200 and is not bent, curved, crimped or severed.
Once the cable is locked, the tensioner may be actuated to regulate tension to the cable. The tensioner may comprise the housing 230, the threaded knob 240, the threaded shaft 220, the crossbar 232, and the retaining feature 221. The threaded knob 240 may be actuated by turning it to provide tension to the cable. As the knob 240 is turned, internal threads 244 engage with the external threads 222 on the threaded shaft 220, and the knob 240 moves distally while the threaded shaft 220 moves proximally as the rotational motion is translated into linear motion. Since the cable is connected to the fixation device at a first location at the distal end segment, and locked within the collet 210 within the shaft 220 at a second location, moving the shaft 220 proximally moves the collet 210 relative to the fixation device, putting tension on the cable between the first location at the fixation device and the second location at the collet.
As the knob 240 moves distally, a distal face 246 of the knob pushes on a spring 248 which surrounds the threaded shaft 220 in the housing 230. As the knob 240 is turned further, the spring 248 is compressed between the knob distal face 246 and a lip 234 formed in the wall of the housing 230. This compression may provide a measure of the amount of force applied to the knob. Indicator markings (shown in Figure A) may be present on the outside of a distal wall 249 of the threaded knob 240 to indicate the amount of force as the knob is turned. The knob 246 is actuated by turning either direction, increasing or decreasing the tension, until a preferred level of tension is reached.
Referring to
A cable collet screw 280 fits within the cable collet anchor 272, held in place by external collet threads 282 which engage with the internal collet threads 278. At a proximal end of the cable collet screw, a shaped inner wall 286 surrounds the cable bore 202. A plurality of flexible fingers 284 extend distally, into the chamber 274. Together the cable collet screw 280 and the cable collet anchor 272 form a locking mechanism.
Extending distally through the insertion guide 166 is a driver shaft 252 of the collet driver 250. As seen in Figure B, the collet driver 250 is captured within the tensioner, but operates independently from the tensioner. A working end 254 of the driver shaft 252 is shaped to mate with the shaped inner wall 286 of the cable collet screw 280. The working end 254 may be shaped as a hexagon or any other shape configured to mate with the cable collet screw.
After the cable has been tensioned as set forth above, the collet driver 250 is actuated to actuate the locking mechanism which includes the cable collet screw 280 and anchor 272. To lock the position of the tensioned cable at a third location, which is relative to the fixation device 102, the cable collet screw 280 is tightened. To tighten the cable collet screw 280, the collet driver 250 is turned, turning the collet driver shaft 252. The working end 254 mates with the shaped inner wall 286 of the cable collet screw, and consequently the cable collet screw 280 is turned. As the collet screw 280 turns and advances within the anchor 272, the fingers 284 advance into the chamber 274. As the collet fingers 284 bias against the tapered wall 276, they are urged together, gripping the cable 116 and locking its position relative to the fixation device 102. In this position, cable 116 is prevented from being pulled in either direction. However, cable 116 can again be freely moved by simply unscrewing collet screw 280 from within the anchor 272 so that fingers 284 are able to freely, outwardly flex.
Once the cable 116 is locked in the cable collet screw 280, the tension on the cable relative to the fixation device 102 is fixed. The proximal collet 210 may be unscrewed, releasing its grip on the cable 116. The housing 230 may be undocked from the insertion guide 166, allowing removal of the tensioner tool 200 from the insertion guide 166. The insertion guide may then be unscrewed and removed from the fixation device 102, leaving the cable 116 locked in the cable collet screw 280. Alternately, the housing 230 may remain docked within the insertion guide 166, and the insertion guide 166 may be uncoupled from the fixation device 102, bringing the docked tensioner tool 200 with it. After both the insertion guide and tensioner tool are removed, the cable 116 extending proximally from the distal collet screw 280 may be cut to a preferred length.
Thus, an improved intramedullary structure has been provided as described above. While the structure has been described in terms of certain specific embodiments, there is no intention to limit the invention to the same. Instead, the invention is defined by the scope of the following claims.
Claims
1. An implantable intramedullary fixation structure adapted to be received in the intramedullary canal of a long bone comprising:
- a plurality of elongated segments, each segment having a first male end and a complementarily-shaped second female end such that an exterior surface of the first male end of a segment cooperatively engages an interior surface of the second female end of an adjacent segment, the segments defining a guide aperture so as to be receivable over a guide for positioning in the intramedullary canal,
- wherein the exterior surface of the first male end comprises four surfaces, a first and second surface being planar and in parallel planes, a third surface being planar and in a plane orthogonal to the first and second surfaces, and a fourth surface in a plane orthogonal to the first and second surfaces and tapered with respect to the third surface.
2. The intramedullary structure of claim 1 further comprising a tensioning member extending the length thereof to apply a compressive force along the longitudinal axis of the structure.
3. The intramedullary structure of claim 1 further comprising at least one fastener received in at least one of the segments for securing the structure in place in the long bone.
4. The intramedullary structure of claim 1 further comprising hardenable surgical fluid for securing the structure in place in the long bone.
5. The intramedullary structure of claim 1 wherein the complementarily-shaped ends of the elongated segments permit relative movement between adjacent segments substantially only axially and in a single plane.
6. The intramedullary structure of claim 1 wherein the fourth surface comprises a plurality of steps.
7. The intramedullary structure of claim 1 wherein adjacent elongated segments are secured to each other.
8. The intramedullary structure of claim 7 wherein adjacent elongated segments are secured to each other by a hinge pin mounted to a segment and received in an elongated slot and an adjacent segment.
9. The intramedullary structure of claim 1 further comprising a radially-expandable member received distally of a distal-most segment and having a cable secured thereto, the cable residing in the guide aperture and extending through the intramedullary structure.
10. The intramedullary structure of claim 9 wherein the expandable member comprises an expander having a plurality of depending legs and a wedge, the cable being secured to the wedge so that when the cable is tensioned, the wedge spreads the legs of the expander radially outwardly.
11. An implantable intramedullary fixation structure adapted to be received in the intramedullary canal of a long bone comprising:
- a plurality of elongated segments, each segment having a first end and a complementarily-shaped second end such that the first end of a segment cooperatively engages the second end of an adjacent segment, the segments defining a guide aperture so as to be receivable over a guide for positioning in the intramedullary canal,
- wherein the complementarily-shaped ends of the elongated segments permit relative movement between adjacent segments substantially only axially and in a single plane,
- wherein the complementarily-shaped ends comprise four surfaces, a first and second surface being substantially planar in line and substantially parallel planes, a third surface being substantially planar in line and a plane substantially perpendicular to the first and second surfaces, and a fourth surface defining a plane generally perpendicular to the first and second surfaces and oblique to the third surface,
- wherein the fourth surface of the elongated segments comprises a plurality of steps.
12. The intramedullary structure of claim 11, further comprising a tensioning member extending the length thereof to apply a compressive force along the longitudinal axis of the structure.
13. The intramedullary structure of claim 11, further comprising at least one fastener received in at least one of the segments for securing the structure in place in the long bone.
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Type: Grant
Filed: Sep 11, 2012
Date of Patent: Jul 30, 2013
Patent Publication Number: 20130006245
Assignee: Sonoma Orthopedic Products, Inc. (Santa Rosa, CA)
Inventors: James D. Stoneburner (Santa Clara, CA), Matthew T. Harmon (Santa Cruz, CA), Roelof Trip (Duluth, CA), Charles E. Larsen (Tampa, FL), Daniel F. Justin (Logan, UT), Karen E. Mohr (Logan, UT), Carlyle J. Creger (River Heights, CA), Mojan Goshayesh (Atherton, CA)
Primary Examiner: Jan Christopher Merene
Application Number: 13/610,686
International Classification: A61B 17/72 (20060101);